Assessment of dialytic efficacy and tolerability of a peritoneal dialysis solution for notturnal exchange containing L-Carnitine in End Stage Renal Disease Patients (ESRD) in Automatised Peritoneal Dialysis (APD) - ND

Active, not recruiting

Conditions: tilization of a peritoneal solution containing L-Carnitine as osmotic agent in the treatment of ESRD patients with APD
MedDRA version: 6.1Level: PTClassification code 10038444

Registration Number: EUCTR2007-000606-75-IT

Lead Sponsor: IPERBOREAL PHARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Age equal/more 18 years 2. Diagnosis of ESRD treated with nocturnal exchange in APD (glucose 1.36 or 2.27%) from at least 1 month 3. Stable clinical condition in the 4 weeks before the Screening Period evaluated by medical history, physical examination, laboratory parameters of renal function and peritoneal permeability 4. Hemoglobin more 8,5 g/100ml 5. No peritonitis in the previous 3 months 6. To be treated in the experimental site from at least 3 months 7. Signed Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Have a history of drug or alcohol abuse in the six months prior to entering the protocol 2.Treatment with androgens 3.Diabetes Mellitus (according to ADA criteria, documented by a fasting glucose and HbA1c) 4.Clinically significant abnormal liver function test (SGOT/SGPT and gammaGT more than 2 times upper normal limit) 5.Presence of infectious conditions 6.Have a history of congestive heart failure and clinically significant arrhythmia 7.History of epilepsy or any NCS disease 8.Have malignancy within the past 5 years, including lymphoproliferative disorders 9.Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient?s safety following exposure to study drug 10.Have a history of L-Carnitine therapy or use in the month prior to entering the protocol 11.Have used any investigational drug in the 3 months prior to entering the protocol 12.Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy and tolerability of a peritoneal dialysis solution for notturnal exchange containing L-Carnitine in End Stage Renal Disease Patients (ESRD) in Automatised Peritoneal Dialysis (APD);Secondary Objective: 1. weekly Kt/V 2. weekly plasmatic Creatinine Clearance(CrCL) 3. PET Creatinine 4. PET Glucose 5. Diuresis 6. ultrafiltration (UF);Primary end point(s): Efficacy and tolerability of a peritoneal dialysis solution for notturnal exchange containing L-Carnitine in End Stage Renal Disease Patients (ESRD) in Automatised Peritoneal Dialysis (APD)

Secondary Outcome Measures